Regulatory Affairs Specialist

We're looking for enthusiastic person to oversee, drive, and maintain the registration process to get import license as required by organization strategy and policy. We're offering opportunity to work with international organization which involved working across SEA region.

Working hours: Mon - Fri, 9.00 - 18.00

Working location: Laksi

Responsibilities:

• Prepare, register, and gather documents related to registration process to get both new and renew import licenses e.g. Certificate of Free Sale/ Certificate of Goods/ Free Sale Certificate, ISO/ any other applicable standard certificate, product catalog/ brochure, Instruction for use/ Notice, and declaration letter (if needed).
• Incorporate with QA/RA manager to oversee the changes and/ or new legislations, requirements, applicable standard and/ or requirement that lead to impact to registration process and Quality Management System.
• Gather, file, and maintain all data/ information regarding FSCA/ AE/ Customer Complaint and any other related QA/RA issues.
• Support any Quality Regulatory Compliance related special projects that assigned by company policy as well as by the change of Thai FDA regulation and requirement.
• Act as Document Control Center to handling all quality and regulatory documents related to applicable standard for Quality Management System.

Requirements:

• Bachelor's Degree in Science, Medical or related fields.
• 1-3 years of experience in Medical Device products registration process or related field.
• Have good experience in working with FDA in preparation of documents for the product registration until product marketing approval.
• Understanding of the rules and regulations of medical products.
• Strong problem-solving and prioritization skills
• Knowledge of registration process and/ or DCC for any applicable QMS (ISO13485).
• Good command in English & Thai both written and spoken.
• Good computer literacy (MS Office: Word, Excel, Access, and Power Point)
• Good coordinator, relationship, and communication skill with other departments.
• Good interpersonal skills and Service Orientation.
• Ability to do multi-tasks & manage priorities under pressure.